Long-term Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis

Phase 3

Completed

• Conditions: Renal Dialysis; Renal Insufficiency; Hyperphosphatemia; Chronic Kidney Disease
• Interventions: Drug: ASP1585

• Registration Number: NCT00892749
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 for long-term dosing in chronic kidney disease and hyperphosphatemia patients on hemodialysis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-30
• Study Start: 2009-05
• Study First Submitted QC: 2009-05-01
• Study First Posted: 2009-05-04
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-30
• Last Update Posted: 2015-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

Inclusion Criteria

• Chronic kidney disease patients on hemodialysis
• Hyperphosphatemia
• Written informed consent

Exclusion Criteria

• Patients with gastrointestinal surgery or enterectomy
• Severe cardiac disease patients
• Patients with severe constipation or diarrhea
• Patients with a complication of malignant tumors
• Patients with uncontrolled hypertension
• Patients treated with parathyroid intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1. ASP1585	ASP1585	-

Primary Outcome Measures

Name	Time	Method
Changes in serum Phosphorus level	After 48 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in intact PTH level	After 48 weeks
Percent of the patients meeting the target range of serum Phosphorus levels	During the treatment
Changes in serum Calcium level	After 48 weeks
Changes in serum Ca x P	After 48 weeks